Recalls / Class I
Class ID-0668-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
- Brand name
- Revitaderm Wound Care
- Generic name
- Benzalkonium Chloride
- Active ingredient
- Benzalkonium Chloride
- Route
- Topical
- NDC
- 63347-120
- FDA application
- M003
- Affected lot / code info
- Lot/Batch #: BL 2844, Expiration date 2/19/2023
Why it was recalled
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Recalling firm
- Firm
- Blaine Labs Inc
- Manufacturer
- Blaine Labs Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 11037 Lockport Pl, N/A, Santa Fe Springs, California 90670-4634
Distribution
- Quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
- Distribution pattern
- Nationwide in 17 States to 45 doctors.
Timeline
- Recall initiated
- 2022-01-25
- FDA classified
- 2022-03-18
- Posted by FDA
- 2022-03-30
- Terminated
- 2022-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0668-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.